Developing Brain Imaging Analysis Expertise for Personalizing Transcranial Electric Stimulation in Anhedonia Treatment of Patients With Bipolar Depression

The purpose of this study is to investigate whether transcranial direct-current stimulation (tDCS) will engage reward-related brain circuitry, more specifically the uncinate fasciculus (UF) tract, which connects the orbitofrontal cortex (OFC) and nucleus accumbens (NAcc) regions. Also to evaluate whether the changes in the fractional anisotropy (FA) of the UF tract are associated with changes of clinical symptoms of anhedonia and finally to investigate the moderation role of simulated electric fields (EFs) in an association between FA of the UF and symptoms of anhedonia.

Study Overview

• Status: Recruiting
• Conditions: Anhedonia
• Intervention / Treatment: Device: active tDCS; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jair C Soares, MD,PhD; Phone Number: (713) 486-2507; Email: Jair.C.Soares@uth.tmc.edu
• Study Contact Backup: Name: Alexandre P Diaz, MD,PhD; Phone Number: (713) 486-2700; Email: Alexandre.PaimDiaz@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Alexandre P Diaz, MD,PhD; Phone Number: (713) 486-2700; Email: Alexandre.PaimDiaz@uth.tmc.edu
      • Contact: Jair C Soares, MD,PhD; Phone Number: 713-486-2507; Email: Jair.C.Soares@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosis of Bipolar Disorder and clinically significant anhedonia
• mild symptoms of depression

Exclusion Criteria:

• substance abuse/dependence and any use of drugs (except alcohol or nicotine) in the previous month of the baseline assessment
• participants with personality disorder that would interfere with study participation according to clinical judgment
• previous neurological conditions (epilepsy, traumatic brain injury, stroke, etc)
• any severe, life-threatening non-psychiatric medical condition
• specific contraindications for tDCS (metallic plates in the head)
• Participants identified as acutely suicidal or severely agitated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS	Device: active tDCS; Subjects will receive active dose (constant current intensity of 2mA) from the tDCS device for 30 minutes per session for two weeks with no sessions on Saturday and Sunday (Monday to Friday), and one additional session two and four weeks later
Sham Comparator: sham tDCS	Device: sham tDCS; Subjects will receive a dose from a "sham-tDCS"that is, a device which delivers a different pattern of electric current for 30 minutes per session for two weeks with no sessions on Saturday and Sunday (Monday to Friday), and one additional session two and four weeks later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the fractional anisotropy of the uncinate fasciculus	Change in the fractional anisotropy of the uncinate fasciculus as assessed by diffusion tensor imaging (DTI)	baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in symptoms of anhedonia as assessed by the Snaith-Hamilton Pleasure Scale modified for clinical administration (SHAPS-C)	This is a 14 item questionnaire and each is scored from 1 to 4 (1 = Lots of pleasure, 4 = No pleasure)	baseline, 6 weeks
change in symptoms of anticipatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)	The TEPS presents 18 items, 10 of them related to the experience of anticipatory pleasure, and the other 8 related to the ability to experience pleasure at the moment. This is scored on a 6-point Likert scale (1 = very false for me to 6 = very true for me).Total scores vary form 18-108 and lower scores mean higher anhedonia	baseline, 6 weeks
change in symptoms of consummatory anhedonia as assessed by the Temporal Experience of Pleasure Scale (TEPS)	The TEPS presents 18 items, 10 of them related to the experience of anticipatory pleasure, and the other 8 related to the ability to experience pleasure at the moment. This is scored on a 6-point Likert scale (1 = very false for me to 6 = very true for me).Total scores vary form 18-108 and lower scores mean higher anhedonia	baseline, 6 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Milken Institute
• Investigators: Principal Investigator: Jair C Soares, MD,PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: bipolar depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Bipolar and Related Disorders; Depression; Anhedonia; Bipolar Disorder
• Other Study ID Numbers: HSC-MS-21-1044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No